NCT06713655Not yet recruiting
Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation
Multicenter Study on PAX1 Methylation for Predicting Lesion Persistence/Recurrence in HSIL Patients with Positive Margins After Cervical Conization
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). The main question it aims to answer is: Can PAX1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence/persistence in addition to existing methods? Participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, PAX1 gene methylation testing, will be added.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 27 Nov 2024
- Start date
- Dec 2024
- Primary completion date
- Apr 2028
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Diseases
- Cervical cancer
- NCT number
- NCT06713655
What you commit to
- Study type: Observational
- Planned participants: 800
- From Dec 2024 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior cervical disease treatment (surgical or physical therapy);
Other illness
- The presence of other malignant tumors or precancerous lesions;
- Presence of immune system disorders.
Other
- Lack of willingness for follow-up;
- Pregnant or breastfeeding women;
- Unable or unwilling to complete follow-up examinations;
Who the study is looking for
- Age greater than 25 years and less than 55 years;
- First-time cervical conization (cold knife conization or loop electrosurgical excision procedure);
- Postoperative pathology showing HSIL (CIN2 or CIN3);
- Positive margins for HSIL (CIN2 or CIN3) in conization specimen.
Age in the registry: 26 years to 54 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Women's hospital school of medicine Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.